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Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of February 4, 2010
TITLE 40--Protection of Environment
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY
SUBCHAPTER A--GENERAL
PART 26--PROTECTION OF HUMAN SUBJECTS
Subpart A--BASIC EPA POLICY FOR PROTECTION OF SUBJECTS IN HUMAN RESEARCH CONDUCTED OR SUPPORTED BY EPA
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| To what does this policy apply? |
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| Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency. |
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| IRB functions and operations. |
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| Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. |
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| Criteria for IRB approval of research. |
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| Suspension or termination of IRB approval of research. |
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| General requirements for informed consent. |
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| Documentation of informed consent. |
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| Applications and proposals lacking definite plans for involvement of human subjects. |
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| Research undertaken without the intention of involving human subjects. |
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| Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency. |
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| Early termination of research support: Evaluation of applications and proposals. |
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Subpart B--PROHIBITION OF RESEARCH CONDUCTED OR SUPPORTED BY EPA INVOLVING INTENTIONAL EXPOSURE OF HUMAN SUBJECTS WHO ARE CHILDREN OR PREGNANT OR NURSING WOMEN
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| To what does this subpart apply? |
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| Prohibition of research conducted or supported by EPA involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or child. |
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Subpart C--OBSERVATIONAL RESEARCH: ADDITIONAL PROTECTIONS FOR PREGNANT WOMEN AND FETUSES INVOLVED AS SUBJECTS IN OBSERVATIONAL RESEARCH CONDUCTED OR SUPPORTED BY EPA
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| To what does this subpart apply? |
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| Duties of IRBs in connection with observational research involving pregnant women and fetuses. |
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| Additional protections for pregnant women and fetuses involved in observational research. |
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| Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material. |
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Subpart D--OBSERVATIONAL RESEARCH: ADDITIONAL PROTECTIONS FOR CHILDREN INVOLVED AS SUBJECTS IN OBSERVATIONAL RESEARCH CONDUCTED OR SUPPORTED BY EPA
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| To what does this subpart apply? |
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| Observational research not involving greater than minimal risk. |
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| Observational research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. |
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| Requirements for permission by parents or guardians and for assent by children. |
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Subparts E-J--[RESERVED]
Subpart K--BASIC ETHICAL REQUIREMENTS FOR THIRD-PARTY HUMAN RESEARCH FOR PESTICIDES INVOLVING INTENTIONAL EXPOSURE OF NON-PREGNANT, NON-NURSING ADULTS
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| To what does this subpart apply? |
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| IRB functions and operations. |
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| Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. |
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| Criteria for IRB approval of research. |
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| Suspension or termination of IRB approval of research. |
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| General requirements for informed consent. |
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| Documentation of informed consent. |
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| Early termination of research. |
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| Prior submission of proposed human research for EPA review. |
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Subpart L--PROHIBITION OF THIRD-PARTY RESEARCH FOR PESTICIDES INVOLVING INTENTIONAL EXPOSURE OF HUMAN SUBJECTS WHO ARE CHILDREN OR PREGNANT OR NURSING WOMEN
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| To what does this subpart apply? |
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| Prohibition of research involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child. |
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Subpart M--REQUIREMENTS FOR SUBMISSION OF INFORMATION ON THE ETHICAL CONDUCT OF COMPLETED HUMAN RESEARCH
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| To what does this subpart apply? |
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| Submission of information pertaining to ethical conduct of completed human research. |
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Subpart N--[RESERVED]
Subpart O--ADMINISTRATIVE ACTIONS FOR NONCOMPLIANCE
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| To what does this subpart apply? |
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| Lesser administrative actions. |
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| Disqualification of an IRB or an institution. |
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| Public disclosure of information regarding revocation. |
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| Reinstatement of an IRB or an institution. |
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| Actions alternative or additional to disqualification. |
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Subpart P--REVIEW OF PROPOSED AND COMPLETED HUMAN RESEARCH
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| EPA review of proposed human research. |
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| EPA review of completed human research. |
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| Operation of the Human Studies Review Board. |
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Subpart Q--ETHICAL STANDARDS FOR ASSESSING WHETHER TO RELY ON THE RESULTS OF HUMAN RESEARCH IN EPA ACTIONS
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| To what does this subpart apply? |
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| Prohibition of reliance on research involving intentional exposure of human subjects who are pregnant women (and therefore their fetuses), nursing women, or children. |
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| Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults conducted before April 7, 2006. |
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| Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults conducted after April 7, 2006. |
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| Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable research. |
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